Prin Software Quality Engr
Responsibilities:
Create and maintain SW and FW quality and performance requirements
and the related metrics
Contribute to test method creation , review and approve
test protocols to support V&V activities for Software and Firmware team.
Leads risk assessments and develop/maintain risk
management files for SW, FW, SOUP and Tools
Actively participate in product development cycle by ensuring
that design control processes are followed, reviewing product project
documentation and owning the closure of the defects.
Partner with cross functional teams and function
seamlessly within the Global Quality team.
Lead resolution to post-market product defects,
complaints, and/or safety issues
Lead adherence to processes for technical design reviews,
code reviews and CCB (Change Control Board) reviews, active member of the
Defect Review Board.
Own quality of technical design reviews, code reviews and
CCB (Change Control Board) reviews.
Assess quality programs and systems with relation to
standards such as IEC 60601-1 and IEC 62304 , ISO 13485 and ensure adherence to
the standards
Drive SOP updates or creation of new processes based upon
upcoming standards or process improvements
Assist in vendor audits to ensure the quality of the
vendor deliverables , assist in internal audits and prepare the team for facing
the audits
Create a culture of quality awareness/focus by mentoring
junior engineers and conducting training sessions
Champion of product quality
Essential Qualifications:
Bachelor’s degree (or higher) in Software/ Computer
Engineering, or equivalent.
12+ years of experience in an engineering role.
Expertise in various phases of SLDC and quality
requirements/standards for medical device industry.
Hands on experience with risk analysis, risk management,
requirements traceability, and Fault Trees or dFMEAS
Experience in conducting DHF Audits, Milestone review
checks and process compliance audits
Strong verbal and written communication skills; ability
to produce high-quality documentation.
Ability to work independently, self-starter and
accountable, with sharp focus on quality and customer experience.
Ability to work in cross-functional and cross-cultural global
teams; Ability to participate in early morning and/or late night calls; Ability
to travel domestically and internationally as required
Nice-to-have Qualifications:
Experience working on embedded systems (Firmware
development)
Working knowledge of Android, Java, C, C++
Knowledge on working using Agile methodologies preferably
Scrum.
Skilled in project leadership practices including ability
to balance risk, effectively influence diverse teams, and ownership of
responsibility for outcomes
Experience with requirements management, version control,
and issue tracking tools
Working knowledge Six Sigma
